The role is critical in the clinical supplies chain; timely evaluation, stability assessment and proving disposition of the impacted clinical supplies to sites are essential in maintaining availability of clinical supplies at sites without disruption.

The role works closely with Global Clinical Supplies, the Global GCD Clinical Supplies Lead SME and several roles in Quality and Continuous Improvement (QCI).

In collaboration with QCI, the role may trigger GCP clinical supplies investigations for Country Operations to complete.

Primary Responsibilities:

• GCP clinical supplies complaint intake, evaluation, product impact assessment and disposition of clinical finished good supplies impacted by temperature excursion
• Manage GCP clinical supplies complaints in centralized system and ensure complete documentation
• Coordinate and/or support the preparation of procedures, processes, and quality improvement activities
• Initiate GCP clinical supplies investigations for GCTO Country Ops to complete
• Provide support for metrics compilation that are presented at various governance councils

Your Profile:

• Bachelor's degree, technical emphasis in an appropriate scientific or engineering field preferred
• 2 years of post-degree experience in the Pharmaceutical or equivalent industry - in Good Clinical Practices (GCP) or Good Manufacturing Practice (GMP) related field, including Technical, Engineering, Quality or Operations
• Effectiveness and creativity in approaching and solving technical problems
• In-depth working knowledge of clinical supplies complaints or GCP related regulatory requirements for supplies as they apply to the pharmaceutical field or a related area
• Basic understanding of MS Office applications
• Evidence of leadership skills coupled with highly developed oral and written communication skills, effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
• Demonstrated teamwork skills and the ability to work independently
• Attention to detail, flexibility and an awareness of production and quality control problems
• Ability to adapt in changing working environment

Preferred Experience and Skills:

• Familiarity with complaints and/or batch disposition (release) activities is a strongly preferred skill necessary for success in this position
• Previous experience in quality control, quality assurance, auditing or regulatory affairs
• Ability to independently manage multiple priorities and projects
• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives
• Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma and Project Management

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
11/4/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R318375